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Published VersionCC BY-NC V4.0, Open Access
Journal article
Parallel randomised trial testing community fibrosis assessment for suspected non-alcoholic fatty liver disease: outcomes from LOCATE-NAFLD
BMJ Open Gastroenterology, Vol.11, pp.1-10
2024
PMID: 39797660
Abstract
Objective: Non-alcoholic fatty liver disease (NAFLD) is estimated to affect a third of Australian adults, and its prevalence is predicted to rise, increasing the burden on the healthcare system. The LOCal Assessment and Triage Evaluation of Non-Alcoholic Fatty Liver Disease (LOCATE-NAFLD) trialled a community-based fibrosis assessment service using FibroScan to reduce the time to diagnosis of high-risk NAFLD and improve patient outcomes.
Methods: We conducted a 1:1 parallel randomised trial to compare two alternative models of care for NAFLD diagnosis and assessment. Participants had suspected NAFLD and were referred to a hepatology clinic in one of three major hospitals in South-East Queensland. Eligible consenting participants were randomised to receive usual care or the intervention (LOCATE). Participants in the intervention arm received a FibroScan outside of the hospital setting, with results provided to their primary care provider and the referring hepatologist. All participants were followed up 12 months after randomisation to measure their clinical and patient-reported outcomes.
Results: 97 participants were recruited from October 2020 to December 2022. Of the 50 participants randomised to the intervention arm, one failed to attend their appointment, and of the 48 (98%) who had a FibroScan 13 (27%) had a liver stiffness measurement of 8.0 kPa or greater. The HR for the time to diagnosis of high risk was 1.28 (95% CI 0.59 to 2.79), indicating a faster average time to diagnosis with the intervention, but failing to conclusively demonstrate a faster time. The intervention did greatly reduce the time to FibroScan by almost 1 year (median difference 0.92 years, 95% CI 0.56 to 1.45). Other clinical outcomes showed minimal changes.
Conclusion: The LOCATE model shows potential for impact, particularly in reducing waiting times for patients at high risk of developing severe liver disease due to NAFLD. A larger sample and longer follow-ups are needed to measure additional clinical outcomes.
Trial registration number: ACTRN12620000158965.
Details
- Title
- Parallel randomised trial testing community fibrosis assessment for suspected non-alcoholic fatty liver disease: outcomes from LOCATE-NAFLD
- Authors
- Ruth Tulleners - Queensland University of TechnologyAdrian Barnett - Queensland University of TechnologyJames O'Beirne - University of the Sunshine CoastElizabeth Powell - Translational Research InstituteIngrid J Hickman - The University of QueenslandPatricia C Valery - QIMR Berghofer Medical Research InstituteSanjeewa Kularatna - Queensland University of TechnologyKatherine Stuart - Princess Alexandra HospitalCarolyn McIvor - Ramsay Health Care (Australia)Elen Witness - Sunshine Coast University HospitalMelanie Aikebuse - Translational Research InstituteDavid Brain (Corresponding Author) - Queensland University of Technology
- Publication details
- BMJ Open Gastroenterology, Vol.11, pp.1-10
- Publisher
- BMJ Group
- Date published
- 2024
- DOI
- 10.1136/bmjgast-2024-001418
- ISSN
- 2054-4774
- PMID
- 39797660
- Copyright note
- This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
- Data Availability
- Data are available in a public, open access repository. Datasets generated and analyses code for all outcomes are available in the GitHub repository for this study. [dataset] Barnett AG, Tulleners R, O’Berine J, et al. Analysis of the NAFLD-LOCATE randomised trial. GitHub, 21 October 2024. https://doi.org/10.5281/zenodo.13959095.
- Organisation Unit
- School of Health and Behavioural Sciences - Legacy
- Language
- English
- Record Identifier
- 991103723602621
- Output Type
- Journal article
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- Gastroenterology & Hepatology
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